Acoustic therapy device

ABSTRACT

The present disclosure provides a device for transmitting focused acoustic energy from a tissue surface of a face of a user to at least one sinus. The device includes a power supply; a signal source configured to provide a waveform of at least 20 kHz that is configured to increase a flow of fluid from the at least one sinus; and a transducer connected to the power supply and the signal source, the transducer configured to contact a medium applied to the tissue surface of the face and transmit the waveform through the medium and the tissue surface of the face to the at least one sinus.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation application of U.S. patentapplication Ser. No. 10/945,331 filed on Sep. 20, 2004. The content ofthe above-identified application is herein incorporated by reference inits entirety.

FIELD

The present disclosure relates to an acoustic therapy device. Morespecifically, the present disclosure relates to a device fortransmitting focused acoustic energy from a tissue surface of a face ofa user to at least one sinus.

BACKGROUND

In the 1970s, the technique of percutaneous transluminal coronaryangioplasty (PTCA) was developed for the treatment of atherosclerosis.Atherosclerosis is the build-up of fatty deposits or plaque on the innerwalls of a patient's arteries; these lesions decrease the effective sizeof the vessel lumen and limit blood flow through the vessel,prospectively causing a myocardial infarction or heart attack if thelesions occur in coronary arteries that supply oxygenated blood to theheart muscles. In the angioplasty procedure, a guide wire is insertedinto the femoral artery and is passed through the aorta into thediseased coronary artery. A catheter having a balloon attached to itsdistal end is advanced along the guided wire to a point where thesclerotic lesions limit blood flow through the coronary artery. Theballoon is then inflated, compressing the lesions radially outwardagainst the wall of the artery and substantially increasing the size ofits internal lumen, to improve blood circulation through the artery.

Other procedures have subsequently been developed for the treatment ofatherosclerosis. These procedures include applying an energy to atreatment site to break-up the fatty deposits or plaque on the innerwalls of a patient's arteries. Such energies can include ultrasonic,microwave, radio frequency, cryogenic, optical laser, thermal, magnetic,pH, etc. Generally, in these procedures, a guide wire is inserted intothe femoral artery and is passed through the aorta into the diseasedcoronary artery. A catheter having an energy transmission deviceattached to its distal end is advanced along the guided wire to a pointwhere the sclerotic lesions limit blood flow through the coronaryartery. Energy, directed from the energy transmission device, is appliedto the inner walls of the artery breaking-up the fatty deposits orplaque. The removal of the fatty deposits or plaque subsequentlyincreases the size of its internal lumen, to improve blood circulationthrough the artery. However, in many instances the accumulation of thefatty deposits or plaque is a recurring or chronic problem, requiringadditional and recurring treatments.

In the 1980s, the technique of extracorporeal shockwave lithotripsy(ESWL) was developed for the management of renal and ureteral calculousdisease. ESWL is a procedure in which renal and ureteral calculi(stones) are pulverized into smaller fragments by shockwaves. Thesesmall fragments then can pass spontaneously. This noninvasive approachallows patients to be rendered stone-free without surgical interventionor endoscopic procedures.

Traditionally, this was accomplished by placing the patient in a largewater bath (e.g., the early-generation machine; Dornier HM3). In newersecond-generation and third-generation devices, the large water bath hasbeen changed to the use of small pools of water or water-filled cushionswith a silicone membrane to provide air-free contact with the patient'sskin. With the new designs, patients can be treated in a variety ofpositions to help in localization and to maximize the effect.

As these examples illustrate, therapeutic energy has been used fortreatment purposes. Nevertheless, there remains a need for improvedsystems and methods for delivering, utilizing, and/or providing energyto a treatment site in a body.

SUMMARY

The present disclosure provides a minimally invasive therapeutic systemfor providing energy to a treatment site within the body of a patient.More specifically, an external power source is provided for transmittingenergy non-invasively through the skin and body of a patient to amedical implant. The medical implant is surgically or percutaneouslypositioned at a treatment site and generally includes an energy focusingdevice. The energy focusing device is configured to receive thetransmitted energy and direct therapeutic energy to the treatment siteto fragment the particulate material.

The medical implant may further include a sensor assembly surgicallypositioned at the treatment site. The sensor assembly may monitor thetreatment site for material build-up. Similarly, the sensor assembly maybe activated by the energy transmitted by the external power source. Theenergy focusing device and sensor assembly may be activated by the samefrequency energy signal. Optionally, the energy focusing device andsensor assembly may be activated by energy signals of differentfrequencies, wherein the external energy unit is configured to transmitenergy signals of different frequencies.

In use, the medical implant is surgically positioned at a treatmentsite. The external energy unit is positioned on a skin portion of thebody of a patient or adjacent thereto, proximal to the treatment site.The energy signal is non-invasively transmitted through the body of thepatient to the medical implant. The sensor assembly may utilize theenergy signal to provide information regarding the treatment site.Similarly, the energy focusing device focuses the energy signal into thetreatment site to fragment the particulate material.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present disclosure, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 depicts a schematic diagram of one embodiment of an energy systemaccording to the present disclosure;

FIG. 2 depicts one embodiment of an energy focusing device according tothe present disclosure;

FIG. 3 depicts a schematic diagram of another embodiment of an energysystem according to present disclosure including an internal RF couplingcoil;

FIG. 4 depicts a schematic diagram of another embodiment of an energysystem according to present disclosure utilizing acoustic wave energy;

FIG. 5 depicts one embodiment of a shaped wire energy focusing deviceaccording to the present disclosure;

FIG. 6 depicts one embodiment of an implantable medical device of thepresent disclosure positioned on an outer surface of a patient's heart;

FIG. 7 depicts another embodiment of an implantable medical device ofthe present disclosure including multiple energy focusing devicespositioned in angular relation;

FIG. 8 depicts another embodiment of an implantable medical device ofthe present disclosure including a sensor assembly;

FIG. 9 depicts another embodiment according to the present disclosureincluding a flow sensor assembly;

FIG. 10 depicts another embodiment of an implantable medical device ofthe present disclosure including a plurality of sensor assemblies;

FIG. 11 depicts another embodiment of an implantable medical device ofthe present disclosure including a power supply;

FIG. 12 depicts the device of FIG. 11 including a rechargeable powersupply;

FIGS. 13A-B depicts another embodiment of an implantable medical deviceof the present disclosure including a stent;

FIG. 14 depicts another embodiment of an implantable medical device ofthe present disclosure including a hip replacement;

FIG. 15 depicts the stent of FIGS. 13A-B including a porous coating;

FIG. 16 depicts the stent of FIGS. 13A-B including a biodegradablecoating;

FIG. 17 depicts another embodiment of an implantable medical device ofthe present disclosure including a heat sink;

FIG. 18 depicts another embodiment of an implantable medical device ofthe present disclosure including a partial coated wire assembly;

FIG. 19 depicts another embodiment of an implantable medical device ofthe present disclosure including an expandable cannula;

FIG. 20 depicts an internal energy unit of the present disclosure beinginserted through an expandable cannula:

FIG. 21 depicts another embodiment of an energy system of the presentdisclosure including a sleeve;

FIG. 22 depicts a partial cross section view of the sleeve of FIG. 20 ona limb of a patient;

FIG. 23 depicts a partial cross section view of the sleeve of FIG. 20 ona limb of a patient including another embodiment of an implantablemedical device of the present disclosure;

FIG. 24 depicts a compressive sleeve for use with the sleeve of FIG. 20:

FIG. 25 depicts another embodiment of an implantable medical device ofthe present disclosure including downstream energy focusing devices; and

FIG. 26 depicts the implanted medical device of the present disclosurebeing utilized on small diameter veins.

DETAILED DESCRIPTION

The present disclosure is directed to a system and method fornon-invasively, or in combination with invasive techniques, providingtherapeutic energy to a treatment site in a patient's body. Morespecifically, an external power source or external energy transmittaldevice is provided for transmitting energy non-invasively through theskin and body of a patient to a medical implant or energy focusingdevice implanted within a patient's body. The medical implant,positioned at a desired treatment site, is configured to receive thetransmitted energy and provide therapeutic energy treatment to thetreatment site.

Referring now to the figures in which like reference numerals refer tolike elements, an exemplary energy system 5 according to the presentdisclosure is shown in FIG. 1. Energy system 5 generally includes anexternal energy unit 10 and an implanted medical device 12. In onepreferred embodiment, external energy unit 10 includes a conventionalalternating current-to-direct current (AC/DC) converter 14 which isconfigured to receive 120 Volt AC electrical power from a conventionalpower source and convert the 120 Volt AC power to a lower magnitude DCvoltage level. An inverter 16 receives the DC voltage via conductors 18and generates an AC current that passes through external coil 20 viaconductors 22 and 24. External coil 20 may be housed within the externalunit 10 or housed separately. In operation, external coil 20 generates achanging magnetic field 26 which may be transmitted to the implantedmedical device 12. The implanted medical device 12 includes an energyfocusing device 28 configured to interact with magnetic field 26 toamplify the energy signal and/or create a convergent point shockwave,vibration, mechanical impulse or force, or other form of therapeuticenergy.

The magnitude and extent of the therapeutic energy or forces created bydevice 28 is configured to be focused or directed toward an adjacenttreatment site to break-up, dislodge, or otherwise fragment particulatematerial such as plaque, clotting, fatty deposits, etc., as the case maybe. In this regard, the particulate material need not be biologicalmaterial. For example, wear debris can be generated in conjunction witha prosthesis such as a total hip implant. Depending upon the implantmaterial, this wear debris can be metallic, polymeric, and/or ceramic.Since the biological response is related to both the type of materialand size of the particulate debris, it may be desirable to apply thetherapeutic energy or forces so that the wear debris is fragmented to agiven size range. Furthermore, the application of the energy or forcesitself may be used to condition the biological response. For example,cells such as macrophages, known to be active in the response to weardebris, can be preferentially attracted or repelled from the site bydevice 28.

It is also envisioned by the present disclosure to use the therapeuticenergy or forces to simply control or modulate fluid flow through avessel. This is described in more detail below.

Referring to FIG. 2, one exemplary embodiment is shown wherein energyfocusing device 28 is a piezoelectric device 30 which generally includesa ferromagnetic plate 32 attached to a ceramic disk 34. In thisembodiment, the alternating current that passes through external coil 20generates a changing magnetic field 26 that interacts with piezoelectricdevice 30 to cause ferromagnetic plate 32 and ceramic disk 34 tovibrate, creating a convergent point shockwave. The frequency andmagnitude of the mechanical vibrations of piezoelectric device 30 areproportional to the magnitude and frequency of the magnetic field 26.

The extent of vibration of piezoelectric device 30 depends, at least inpart, on the physical placement of external coil 20 relative to thepiezoelectric device 30. To maximize energy efficiency, the externalcoil 20 may be positioned such that a maximum number of lines ofmagnetic flux of magnetic field 26 cross the surface of theferromagnetic plate 32. In this regard, external coil 20 may beoptimally positioned on the skin directly over the site at which theimplanted medical device 12 is located.

Referring to FIG. 3, another embodiment of an energy system is shownwhich includes a radio frequency (RF) coupling coil 36 implanted withina patient's body configured for receiving RF energy from an external RFtransmitter 42. In operation, RF transmitter 42 may be disposed oppositethe RF coupling coil 36 external to the patient and the RF coupling coil36 may provide power to the implanted medical device 12. The external RFtransmitter 42 includes a toroidal coil 46 disposed within the hollowcenter portion of a toroidal-shaped core 48. A housing 50 comprising anRF shield encloses much of the toroidal coil 46 and core 48. As notedabove, when AC current passes through coil 46, lines of magnetic flux 54intersect RF coupling coil 36 to provide electrical power for energizingthe implanted medical device 12.

As shown in FIG. 3, the RF coupling coil 36 is a wound toroidal coilincluding a plurality of conductor coil loops 52. Although the drawingshows only a single coil 36 of spiral coil loops 52, it is contemplatedthat a plurality of coils of such coil loops may be used and that thespacing between coil loops 52 may be substantially closer than as shown.

In one embodiment, the implanted medical device 12 may additionallyinclude a piezoelectric device 30. In operation, the alternating currentpassing through the RF coupling coil 36 causes ferromagnetic plate 32,and piezoelectric ceramic disk 34 to vibrate, creating a convergentpoint shockwave. The frequency and magnitude of the mechanicalvibrations of piezoelectric device 30 are proportional to thealternating current passing through RF coupling coil 36.

Referring now to FIG. 4, an alternative energy system is shown whichutilizes acoustic waves rather than a magnetic field to power/excite theimplanted medical device 12. An external energy unit 56 includes anacoustic signal source 58 connected to an emitter 60 through conductors62 and 64. Emitter 60 includes a piezoelectric transducer or any otheracoustic source capable of emitting acoustic waves receivable by theimplanted medical device 12. The frequency of the acoustic waves may bein any suitable range including, but not limited to, frequencies in theultrasonic (frequencies generally higher than 20 KHz), sonar (generally25-100 KHz), medical ultrasonic (generally 1-10 MHz), and microwaveacoustic (frequencies generally over 50 MHz) ranges. As is well known, alotion or gel can be used in conjunction with the external energy unitto maximize the transmission of the acoustic waves though the skin ofthe patient.

As noted above, medical device 12 may include a piezoelectric device 30having a ferromagnetic plate 32 attached to a ceramic disk 34. Inoperation, waves 66 from the emitter 60 impinge on piezoelectric device30 causing plate 32 and piezoelectric ceramic disk 34 to vibrate andemit a convergent point shockwave. In a preferred embodiment, thefrequency of the waves emitted by the emitter 60 may be selected tomatch the resonate frequency of the piezoelectric device 30 to optimizevibration.

An alternative energy system uses extracorporeal shockwaves (ESW) topower/excite the implanted medical device 12. The ESW system includes anenergy source (the shockwave generator), a focusing system, and acoupling mechanism.

The shockwave generator can take the form of electrohydraulic,piezoelectric, and/or electromagnetic energy. In an electrohydraulicgenerator, an electrical discharge of a high-voltage current occursacross a spark-gap electrode located within a fluid-filled container.The electric discharge results in a vaporization bubble, which expandsand immediately collapses, generating a high-energy pressure wave. In apiezoelectric generator hundreds-to-thousands of ceramic or piezocrystals are set in a fluid-filled container and are stimulated with ahigh-energy electrical pulse. The high-energy electrical pulse vibratesor rapidly expands the crystals, leading to a shockwave that can bepropagated through the fluid. In an electromagnetic generator, anelectrical current is applied to an electromagnetic coil mounted withina fluid-filled cylinder. The magnetic field causes an adjacent metallicmembrane to be repelled by the coil, resulting in extremely rapidmovement of the membrane, producing a shaped shockwave. Exemplaryshockwave generators are provided in U.S. Pat. Nos. 2,559,227, 4,947,830and 5,058,569, the contents of which are herein incorporated byreference.

The focusing system concentrates and directs the shockwave energy intothe body of the patient. For example, an electrohydraulic systemutilizes the principle of the ellipse to direct the energy created fromthe spark-gap electrode. Piezoelectric systems arrange their crystalswithin a hemispherical dish, arranged so that the energy produced isdirected toward one focal point. Electromagnetic systems use either anacoustic lens or a cylindrical reflector to focus their waves.

The coupling system transmits the energy created by the shockwavegenerator to the skin surface and through body tissues into the patient.The coupling system can take the form of a large water bath in which thepatient is submerged. Alternatively, the coupling system can be smallpools of water or water-filled cushions with a silicone membrane toprovide air-free contact with the patient's skin.

In the above embodiments, the external energy unit 10 transmits a steadyenergy signal to the energy focusing device 28, resulting in a steadytreatment energy signal to the treatment site. It is contemplated thatthe external energy unit 10 may provide a pulsated energy signal to theenergy focusing device 28, resulting in pulsated treatment energydelivered to the treatment site. Additionally, the frequency and/orwavelength of the transmitted energy may be modulated, therebymodulating the treatment energy signal.

It should be emphasized that the present disclosure is not limited tothe energy units described above. Other energy units include, but arenot limited to, radio frequency (RF), magnetic, electro magnetic (EM),acoustic, microwave, thermal, vibratory, radiation, or extracorporealshockwave (ESW) energies, alone or in any combination thereof.Furthermore, the frequency and/or wavelength of the transmitted energymay be adjusted, depending of the depth, size, density, location, etc.of the treatment site.

In the foregoing embodiments, the energy focusing device 28 has beendescribed as including a piezoelectric device 30. However, in alternateembodiments any energy focusing device 28 may be used which can convertexternally transmitted energy into an in vivo focused energy source,such as a convergent point shockwave. Referring to FIG. 5, analternative embodiment is shown wherein energy focusing device 28includes a shaped wire or rod 68 configured for receiving and radiatingthe externally transmitted energy 70. The shaped wire 68 resonates whenexposed to the externally transmitted energy 70 from an external energyunit 10. The frequency of the signal 70 and the configuration of theshaped wire 68 may be selected such that shaped wire 68 resonates whenexposed to the transmitted energy, emitting a convergent pointshockwave. For example, the frequency of the transmitted energy and theconfiguration of the shaped wire 68 may be selected such that the shapedwire 68 resonates at a frequency of about between 1-10 MHz. Aspreviously noted, the frequency or wavelength may be varied.

In the foregoing embodiments, the energy focusing device 28 has beendescribed as any energy focusing device 28 which can convert externallytransmitted energy into a convergent point shockwave. However, it iscontemplated that the energy focus device 28 may be any device which isconfigured to receive and convert an external energy signal into aninternal energy, directing the internal energy into the treatment site.Non-limiting example of the converted and directed internal energiesinclude, radio frequency (RF), magnetic, electro magnetic (EM),acoustic, microwave, thermal, vibratory, radiation, or extracorporealshockwave (ESW) energies, alone or in any combination thereof.

Referring now to FIGS. 6 and 7, one exemplary practical application ofan energy unit according to the present disclosure is shown wherein theimplanted medical device 12 is implanted or surgically positioned on orproximal to an outer surface of the aorta 74 of the heart 76. Imagingtechniques, such as MRI, CT scan, ultrasound, x-ray, fluoroscope, etc.,may be used in the implantation of the medical device 12, aiding in thepositioning of the medical device 12. Medical device 12 is implanted ata distance F1 from the skin surface of the patient. The implantedmedical device 12 is positioned adjacent to a treatment site 78, whichmay be, for example, an area of recurring clotting or stenotic area. Atperiodic time intervals, the implanted medical device 12 may beactivated to break-up or fragment particulate material to treat, forexample, clotting or stenosis. As discussed above, the implanted medicaldevice 12 is activated by positioning the external energy unit 10 on theskin of the patient's body, adjacent to and aligned with the implantedmedical device 12. Energy is transmitted through the body of the patientto the implanted medical device 12, such that the energy signal istransmitted to the energy focusing device. The implanted medical device12 is positioned on the treatment site 78 such that the energy focusingdevice 28 directs the energy signal into the treatment site 78. Forexample, the energy focusing device 28 creates a convergent pointshockwave focused into the clot or stenotic area at a distance F2 fromthe energy focusing device 28, breaking-up or fragmenting particulatematerial in the clot or stenotic area. The energy focusing device 28 canbe used for a single treatment or multiple treatments.

In one alternative embodiment, the implanted medical device 12 includesa plurality of energy focusing devices 28, implanted or surgicallypositioned on or proximal to an outer surface of the aorta 74 of theheart 76 of the patient. Each of the energy focusing devices 28 ispositioned adjacent to a treatment site 78, an area of recurringclotting or stenotic areas. Each of the energy focusing devices 28 maybe activated by positioning an external energy unit 10 on the skin ofthe patient's body, adjacent to and aligned with each of the energyfocusing devices 28. In this regard, energy may be transmitted throughthe body of the patient to each of the energy focusing devices 28. Eachof the energy focusing devices 28 may be activated by a single type ofenergy unit 10 or different energy focusing devices 28 may be activatedby different types of energy units 10. For example, a first energyfocusing device may be activated by ultrasonic energy and a secondenergy focusing device may be activated by a RF signal. Similarly, theenergy focusing devices 28 may be configured to receive and/or transmita single frequency/wavelength or a range of frequencies/wavelengths.

It may be beneficial to have a first group of energy focusing devices 28that is responsive to a first range of frequencies and a second group ofenergy focusing devices 28 that is responsive to a second range offrequencies, with the first range differing from the second range. Forexample, if the first group is located in a different area of medicaldevice 12 than the second group, treatment area 78 can be localized. Itmay also be advantageous to have the first and second groupsintermingled. In this situation, activation of only one of the groupswould provide a given level of energy that may be sufficient for thedesired effect. If it is not, activation of the second group can beinitiated (while maintaining activation of the first group) to increasethe level of energy. Thus, the intended clinical result can be achieved,while minimizing potential deleterious effects, such as tissue necrosis,of unneeded energy levels.

The plurality of energy focusing devices 28 may be positioned about asingle treatment site 78, wherein the energy focusing devices 28 may beactivated in unison or selectively to broadly cover the treatment site78. In one embodiment, the energy focusing devices 28 may be positionedat angular relationships .alpha. to each other, directing the convergentshockwaves into the treatment site at differing angles, such that theangles of the convergent shockwaves intersect at specific angles ordepths within the treatment site to fragment particulate material. In analternative embodiment, each of the energy focusing devices 28 may beactivated individually, wherein each energy focusing device 28 may beattuned to a different activation frequency to selectively activatevibration points or convergent point shockwaves, as may be desired by aphysician practitioner.

In another alternative embodiment, each of the plurality of the energyfocusing devices 28 may be positioned at different treatment sites. Inoperation, an individual energy focusing device 28 may be selected foractivation dependent on the presence of clotting or a stenotic area. Theselected energy focusing device 28 may be activated by positioning anexternal energy unit 10 on the skin of the patient's body, aligned withthe selected energy focusing device 28. Energy is transmitted throughthe body of the patient to the selected energy focusing device 28. Theselected energy focusing device 28 is positioned on the treatment sitesuch that a shockwave is directed into the treatment site 78,fragmenting or breaking-up the clot or stenotic area. In one embodiment,each of the energy focusing devices 28 is attuned to activate atsubstantially the same frequency. Alternatively, each of the energyfocusing devices 28 may be attuned to be activated at differentfrequencies. Although the foregoing exemplary embodiment has beendescribed using a single type of external energy unit for activating theenergy focusing devices 28, it is contemplated that multiple types ofexternal energy units may be used, wherein individual implanted medicaldevices may be activated by different energy units.

In the above examples, the present disclosure has been described astreating clotting and stenotic areas in the heart. However, it iscontemplated that the present disclosure can be used on any organ orportion of the body requiring periodic breaking or fragmenting ofparticulate material, burning off endothelium or tissue overgrowth,breaking up or preventing scar tissue after surgery, breaking-upadhesions or damage to the intestines or other areas, treating tumors orcarcinogenic tissue, breaking up calcific deposits, including myossitisossificans or heterotopic tissue. For example, the present disclosurecan be used on the kidney to aid in the breaking-up or fragmenting ofkidney stones. Alternatively, the present disclosure can be used atjoints in the body to break-up calcium deposits.

In addition to or in combination with breaking-up particulate material,the present disclosure can be used in the treatment of vessel spasm. Forexample, during any acute myocardial infarction the blood flow isreduced due to a clotting of the vessel. Additionally, the vessel canvasospasm, narrowing vessel diameter and thereby further reducing theflow of blood. The present disclosure can treat the vasospasm bydirecting energy into the vessel, dilating the vessel to increase theblood flow therein. Furthermore, during a procedure to remove theclotting material an energy focusing device 28 of the present disclosurecan be positioned adjacent to the vessel to focus energy into thevessel. The energy is focused on the vessel to relieve the vasospasm,increasing the diameter of the vessel. The increased diameter of thevessel has the beneficial effect of recreating a laminar flow in theonce restricted portion of the vessel. It is contemplated that thepresent disclosure can be used singularly or in combination withvasospasm treating medication. The above example noted the treatment ofvasospasms, however the present disclosure can be used to treat anyspasm in a vessel, for example reflux, colorectal spasm, etc.

In another exemplary application, the present disclosure can be used infertility treatment (or conversely, birth control). Energy can beapplied to stimulate release of an egg from the ovaries and into thefallopian tubes. As noted above, energy can be applied to control thetravel of the egg through the fallopian tubes. The energy can also beused to increase motility of the sperm.

Applicant's published U.S. patent applications, U.S. Publication Nos.2004/0084568 and 2004/0084569, the contents of which are hereinincorporated by reference, are relevant in this regard. In theseapplications, the use of energy to modulate drag and thrust isdisclosed. The drag is actively modulated by energy beams which mayeither increase or decrease the drag. The energy beams may provideenergy at a transition region between turbulent and laminar flows or atthe leading edge of a laminar flow in order to facilitate the respectiveincrease or decrease in drag. These principles are readily transferableto flow within vessels of the body.

The present disclosure has been previously described as treating orbreaking particulate material in the body of the patient. However, it iscontemplated that the present disclosure can be used to elicit localizedbiological responses in the body of the patient. For example, thebreaking-up or fragmentation can result in a localized release ofenzymes, proteins, or viral RNA from within the cells or externally. Theuse of commercially available factors such as OP-1 (from StrykerCorporation) and INFUSE (from Medtronic) is also contemplated.Additionally, the present disclosure can be used to accelerate or reducethe lysis, especially when used in combination with pharmaceuticaltreatments.

It is contemplated that imaging techniques and devices may be used inconjunction with the system of the present disclosure. An imaging devicemay be used to diagnosis the condition requiring treatment, determiningthe characteristic of the treatment site. Upon the application of thetreatment energy from the energy focusing device 28, the imaging devicemay be used to determine if further treatment is required and toperiodically monitor the treatment site. Acceptable imaging devices caninclude, but are not limited to, MRI, CT scan, ultrasound, x-ray,fluoroscope, etc. Furthermore, when used with imaging devices, such asan MRI, the energy focusing device 28 may act as a secondary coil,providing greater clarity of the treatment site.

Referring to FIGS. 8 and 9, in an alternate embodiment, the implantedmedical device 12 may further include at least one sensor assembly 80for monitoring the patient. An exemplary sensor assembly 80 is a flowsensor assembly 82 for monitoring the blood flow through an artery,vein, or other vessel. The flow sensor assembly 82 includes a transducer84 for transmitting an acoustic signal 86 and a receiver 88 forreceiving the acoustic signal 86. The flow sensor assembly 82 is used tomonitor the flow of blood, including the velocity and volume through thevessel. The flow sensor assembly 82 can be activated by a signal fromthe external energy unit 10 or can be programmed to transmit readings atgiven intervals or when a recorded parameter exceeds a given thresholdlevel. Exemplary flow sensor assemblies 82 are disclosed in U.S. Pat.No. 6,398,743, to Cimochowski et al., the content of which isincorporated by reference. Other sensor assemblies that may be used withthe present disclosure can include, but are not limited to, temperaturesensor assemblies, pressure sensor assemblies, tension sensorassemblies, and density sensor assemblies, etc.

As is well-known, the sensor assemblies can include means fortransmitted the measured parameters to a remote location so that atrained healthcare provider can monitor the readings. Pending U.S.patent application Ser. No. 10/421,965 filed Apr. 23, 2003, the contentsof which are incorporated by reference, discloses one mechanism that canbe used in this regard.

In alternate embodiments, sensor assemblies may be used in conjunctionwith any type of implantable medical device such as, but not limited to,tissue grafts, screws, plates, rods, prosthetic devices, etc. Thesensors could be made to include any suitable material, including butnot limited to, wires, capacitors, silicone chips, and partial orcompletely biodegradable materials. The sensors could also be made todetect heat variations, cooling energy, pH gradients, electrical charge,electrolytes, magnetic charge, changes in local chemistry, etc., and maybe designed to monitor such things as loosening of implants, thestability of hardware, or the growth rate of cancer, among other things.The sensor can be made of or partial made of a biodegradable orbioreabsorble material, which can include, but not be limited to,silicone, iron, or copper.

Referring now to one embodiment of a method of use of the presentdisclosure, medical device 12 is surgically positioned on a vessel andlocated at an area of reoccurring plaque build-up, for example. Theimplantable medical device 12 generally includes a plurality of energyfocusing devices 28 and at least one flow sensor assembly 82. The energyfocusing devices 28 and the flow sensor assembly 82 are preferablyattuned to be activated at different frequencies transmitted from anexternal energy unit 10. Initially, the baseline blood flow through thevessel in a clean state, absent plaque, is determined. The baselineblood flow may be determined using the flow sensor assembly 82 or otherknown devices. At a set time interval, or check-up date, the vessel maybe subsequently checked for plaque build-up or stenosis. To check thevessel, the flow sensor assembly 82 may be activated by positioning theexternal energy unit 10 on the skin of the patient's body, adjacent toand aligned with the flow sensor assembly 82. Energy is transmittedthrough the body of the patient to the flow sensor assembly 82. Theexternal energy unit 10 transmits the energy at a first frequency,attuned to activate the flow sensor assembly 82. The flow sensorassembly 82 is positioned on the vessel such that an acoustic signal isdirected into the vessel to determine the blood flow in the vessel. Ifthe blood flow is less then the baseline blood flow, plaque may bepresent in the vessel.

To break-up or fragment the plaque, one or more of the energy focusingdevices 28 are activated. As discussed above, each of the energyfocusing devices 28 may be activated by positioning the external energyunit 10 on the skin of the patient's body, aligned with the energyfocusing device 28. In a preferred embodiment, energy is transmittedthrough the body of the patient to the energy focusing device 28 at asecond frequency attuned to activate one or more of the energy focusingdevices 28. The energy focusing devices 28 are positioned on the vesselsuch that a convergent point shockwave may be directed from each energyfocusing device 28, breaking-up the plaque or fragmenting particulatematerial that may be causing restricted blood flow.

The blood flow through the vessel may then be rechecked using the flowsensor assembly 82, and compared to the baseline blood flow. If theblood flow is substantially equal to the baseline blood flow thetreatment is ended. If the blood flow is less then the baseline bloodflow, the treatment may be repeated, as desired by a physicianpractitioner. This process may be continued until the blood flow issubstantially equal to the baseline blood flow or a suitable amount offlow is achieved, as determined by a physician practitioner.

In alternate embodiments, the implanted medical device 12 can include aplurality of sensor assemblies 80 and energy focusing devices 28positioned along and about the vessel. The sensor assemblies 80 may beused in conjunction to determine the position of the plaque build-up inthe vessel, and to select which of the energy focusing device(s) 28 isto be activated or used to break-up the plaque or fragment theparticulate material.

Referring to FIG. 10, in one embodiment the implanted medical device 12includes a plurality of flow sensor assemblies 82 and density sensorassemblies 90, positioned along and about the vessel. Adjacent to eachpair of sensor assemblies 82 and 90 is an energy focusing device 28.Each of the sensor assemblies 82 and 90 and the energy focusing devices28 may be attuned to different activation frequencies. For example, thedensity sensor 90 can be an ultrasonic sensor and may also be used todetermine the depth of the plaque.

In operation, the sensor assemblies 82 and 90 may be initially activatedby positioning the external energy unit 10 on the skin of the patient'sbody, aligned with the vessel 92. Energy is transmitted through the bodyof the patient to the sensor assemblies 82 and 90. Thefrequency/wavelength of the energy may be selectively modulated, or inthe alternative, continually modulated to individually activate thesensor assemblies 82 and 90. In this regard, the flow sensor assemblies82 may determine the blood flow at different locations along the vessel92. The density sensor assemblies 90 may determine the vessel wallthickness, including plaque thickness, at different locations. Theinformation from the individual sensor assemblies 82 and 90 may be usedto construct an image of the vessel 92 for viewing on an externalmonitor, wherein the physician practitioner may use the information todetermine and adjust the treatment. Using the constructed image, theappropriate energy focusing device(s) 28 may be selected for activationto break-up or fragment the plaque or particulate material. After aninitial treatment with the energy focusing device(s) 28, the vessel canbe re-imaged to determine if further treatment is required. This processmay be repeated until the vessel 92 is substantially free of plaquebuild-up or a suitable amount of flow is achieved, as determined by aphysician practitioner.

In one alternative embodiment, the medical device 12 of the presentdisclosure is positioned proximal to a joint in the body of a patient.The medical device includes pressure sensor assemblies positionedproximal to or within the joint. Energy focusing devices 28 arepositioned to direct a convergent point shockwave into the joint. Thepressure sensor assemblies may be used to detect an increase jointpressure, which may indicate a buildup of particulate material withinthe joint. As described above, the energy focusing devices 28 may thenbe activated, directing a convergent point shockwave into the joint, tobreak-up or fragment the particulate material, relieving the pressure inthe joint.

Referring to FIG. 11, in one alternate embodiment the implanted medicaldevice 12 may further include a power supply 98 operably connected tothe energy focusing device(s) 28 and the sensor assembly(s) 80. Acontrol unit 100 including a processing unit 102 is interposed betweenthe energy focusing device(s) 28 and the sensor assembly(s) 80 and thepower supply 98. In operation, the control unit 100 is configured toselectively activate the sensor assembly(s) 80 to image the vessel at aset time interval. In response to the imaging, if required, the controlunit 100 may also selectively activate one or more energy focusingdevice(s) 28 to break-up the plaque or fragment particulate materialthat may be causing restricted blood flow. After an initial treatmentwith the energy focusing device(s) 28, the vessel may be re-imaged todetermine if further treatment is required. This process may repeateduntil the vessel is substantially free of plaque or a suitable amount offlow is achieved, as may be determined by pre-set parameters programmedinto control unit 100.

In an embodiment, the control unit 100 may be controlled from anexternal unit. The control unit 100 further includes a transceiver 103configured to receive an external signal. The transceiver 103 activatesor deactivates the medical device 12 in response to the external signal.For example, the transceiver may be configured to receive an RF signal.

In another alternate embodiment, the control unit 100 may furtherinclude electronic memory 104, for storing imaging and treatmentinformation. A transmitter 106 may be included for downloading thestored information to an external receiving unit. The external receivingunit can be a computer, including a CPU and a display unit, or any otherprocessor. The computer can be connected to a global computer network,allowing the stored information to be transmitted across the globalcomputer network to remote medical personnel. The stored information canprovide a continual history of the patient's plaque build-up andsubsequent treatment(s) for review and analysis by medicalpractitioners. The electronic memory 104 may include a radio frequencyidentification chip (RFID), which is activated by an RF signal totransmit the stored information.

Referring to FIG. 12, in one embodiment the power supply 98 includes arechargeable battery 110. The rechargeable battery 110 may be rechargedby positioning the external energy unit 10 on the skin of the patient'sbody, adjacent to and aligned with the rechargeable battery 110. Energyis transmitted through the body of the patient to the rechargeablebattery 110. In one embodiment, the rechargeable battery 110 includes apiezoelectric device 30. As noted above, an exemplary piezoelectricdevice 30 includes a ferromagnetic plate 32 attached to a ceramic disk34. The external energy unit 10 causes the piezoelectric ceramic disk 34to vibrate generating a voltage which recharges battery 110. Anexemplary energy system for non-invasively recharging an implantrechargeable battery is disclosed in U.S. Pat. No. 5,749,900, toSchroeppel, the contents of which are incorporated by reference.Alternatively, the external energy system may be percutaneously ortranscutaneously positioned proximal to the rechargeable battery 110.

In the above embodiment, the rechargeable battery 110 is described asrequiring an external energy unit 10 to be recharged. However it iscontemplated, that the rechargeable battery can include aself-recharging mechanism. The self-recharging mechanism utilizes themovement of the patient to generate power to recharge the rechargeablebattery.

Referring to FIG. 13A-B, in one alternative embodiment, the implantedmedical device 12 may include a stent 112, positionable in a vessel of apatient. The stent 112 includes at least one energy focusing device 28.As noted above, an exemplary energy focusing device 28 is apiezoelectric device 30 which includes a ferromagnetic plate 32 attachedto a ceramic disk 34. The piezoelectric device(s) 30 can be activated bypositioning an external energy unit 10 on the skin of the patient'sbody, aligned with the piezoelectric device(s) 30. Energy is transmittedthrough the body of the patient to the piezoelectric device(s) 30. Thepiezoelectric device(s) 30 is positioned on the stent 112 to preventrestenosis or plaque build-up.

In an alternative embodiment, a plurality of energy focusing devices 28may be positioned on and about stent 112. Each of the energy focusingdevices 28 may be activated by positioning an external energy unit 10 onthe skin of the patient's body, aligned with the energy focusing devices28. Energy is transmitted through the body of the patient to the energyfocusing devices 28 (or a given subset as previously described). Theimplanted stent 112 may further include at least one sensor assembly 80positioned on the stent 112 for monitoring various conditions of thepatient. As noted above, an exemplary sensor assembly 80 is a flowsensor 82 for monitoring the blood flow through the vessel. The flowsensor assembly 80 may be used to monitor the flow of blood, includingthe velocity and volume through the stent. If flow sensor assembly 80detects a decrease in the blood flow through the stent 112, restenosisor plaque build-up may be present. The energy focusing device 28 canthen be activated to break-up or fragment the particulate material. Anexemplary stent 112 including a sensor assembly is disclosed in U.S.Pat. No. 5,967,986, to Cimochowski et al., the contents of which areincorporated by reference.

In the above exemplary embodiments, the present disclosure is utilizedto break-up or fragment particulate material within the body of thepatient. In an alternative embodiment, the present disclosure can beused to elicit a localized biological response in the body of thepatient. The present disclosure can provide a disruptive energy causinga localized change in temperature, change in PH, or local cellulardamage. This can result in the release of enzymes, proteins, or viralRNA (or the previously identified commercially available products) fromwithin the cells or externally. Additionally, an increase in temperaturecan have the beneficial effects aiding in the alleviation of localizedpain, fighting of local infections, and increasing vascular flow andpermeability of vessels at the treatment site.

While in the foregoing exemplary embodiment the implanted medical device12 was depicted specifically with a stent 112, the energy focusingdevice 28 and sensor assemblies 80 may be used in conjunction with othertypes of implantable medical devices 12. Non-limiting examples includehip and knee replacements (total and partial), spinal implants, tissuescaffolds, tissue fasteners, screws, plates, rods, prosthetic devices.Furthermore, the implantable medical devices 12 may be a biodegradable,bioreabsorbable, and/or biologic implant, including tissue scaffoldswhich may include stem or fetal cells, tissue grafts, cellular implants,organ transplant implants, biologic grafts, osteochondral grafts,autografts, allografts, or xenografts.

Applicant's published U.S. patent application, U.S. Publication No.20040078073, the contents of which are incorporated by reference,discloses tissue scaffolds and associated methods. The presentdisclosure can be used to improve the fragmentation of these scaffoldsso they would become more biologically tolerated. In other words, thestem cells or fetal cells in the scaffold would remain viable, but thescaffold could be degraded as needed. Once the tissue starts tofunction, the tissue scaffold could be externally broken up and ensuretheir more rapid degradation while the cells or cell therapy remainviable within the body. In order to hasten the degradation, energy couldbe applied to accelerate the degradation of the scaffold withoutaffecting the cell viability. Voids or defects could be placed into thescaffold, such as bubbled areas. These would serve as preferential areasof degradation. As has been previously discussed, the energy appliedcould be selected to lyse the cells, thereby releasing enzymes,hormones, etc. This would effective create a localized biological orgene therapy.

Referring to FIG. 14, the implantable medical device 12 includes a hipreplacement system 117. The energy focusing device is positioned on orincorporated into the hip replacement 117 to transmit energy into thehip joint 119. Additionally, the internal power supply 98 may beattached to or incorporated into the hip replacement 117.

Referring again to FIGS. 13A-B, the exemplary stent 112 may be coatedwith a pharmaceutical agent 114. The pharmaceutical agent 14 may bephysically and/or chemically bonded to the surface of the stent 114 by,for example, but not limited to, covalent bonding, ionic bonding,VanderWal forces, magnetic forces, etc. For example, numerouspharmaceutical agents are being actively studied as antiproliferativeagents to prevent restenosis and have shown some activity inexperimental animal models. These include, but are not limited to,heparin and heparin fragments, colchicine, taxol, angiotensin convertingenzyme (ACE) inhibitors, angiopeptin, Cyclosporin A, goat-anti-rabbitPDGF antibody, terbinafine, trapidil, interferon-gamma, steroids,ionizing radiation, fusion toxins, antisense oligonucleotides, genevectors, and rapamycin. An exemplary stent 112 including apharmaceutical agent 114 coated thereon is disclosed in U.S. Pat. No.6,585,764, to Wright et al., the contents of which are incorporated byreference. Applicant's U.S. Pat. No. 5,163,960, the contents of whichare incorporated herein by reference, discloses an implant device(including an expandable device) may be provided with a coating thatcontains a therapeutic agent.

In addition to or as an alternative to, the stent 112 may be coated witha therapeutic or biologic agent. Non-limiting examples include hormones,cells, stem cells, bone morphogenic proteins (BMPs), enzymes, proteins,RNA, etc.

In one embodiment of the present disclosure, a pharmaceutical agent 114may be affixed to the stent 112 by coating, mixing, or bonding thepharmaceutical agent 114 to a polymer coating 116 applied to the stent112. In this regard, the polymer coating 116 may be configured to be areactive coating, reacting to energy provided by an external energy unit10. Referring to FIG. 15, in one exemplary embodiment, the polymercoating 116 is a porous coating, which acts as a membrane to diffuse thepharmaceutical agent 114. Initially, the pores 118 in the coating areclosed or sufficiently small in size to restrict the release of thepharmaceutical agent 114. In operation, the external energy unit 10 maybe positioned over the stent 112 and provide energy to heat the stent112 and polymer coating 116, opening or increasing the size of the pores118 to selectively release the pharmaceutical agent 114. After atherapeutic amount of the pharmaceutical agent 114 has been released,the applied energy may be discontinued, closing the pores 118. Thepolymer coating 116 may be attuned for activation at substantially thesame frequency as the energy focusing device 28. Alternatively, polymercoating 116 may be attuned to be activated at a different frequency fromthat of the energy focusing device 28.

Referring to FIG. 16, in another embodiment, the polymer coating 116 maybe a biodegradable coating 120. In operation, the external energy unit10 may be positioned over the stent 112, providing energy at a frequencyto heat the stent 112 and polymer coating 116, partially breaking-up orfragmenting the biodegradable coating 120 from the stent 112. Theapplied energy increases the degradation, fragmentation, or dissolutionrate of the biodegradable coating 120, to accelerate the release of thepharmaceutical agent 114. After a therapeutic amount of thepharmaceutical agent 114 has been released, the energy may bediscontinued. The biodegradable coating 120 may be attuned foractivation at substantially the same frequency as the energy focusingdevice 28. Alternatively, biodegradable coating 120 may be attuned to beactivated at different frequency from that of the energy focusing device28.

In an embodiment, stent 112 may include a plurality of layers orsections of biodegradable coatings 120, each including a differenttherapeutic amount of a pharmaceutical agent 114. The external energyunit 10 may be used to apply energy to selectively release a layer ofthe biodegradable coating 120, releasing the corresponding therapeuticamount of a pharmaceutical agent 114. Each of the layers or sections ofthe biodegradable coating 120 may be released as needed or at set timeintervals.

Similarly, the plurality of layers or sections of biodegradable coatings120 may each including a different pharmaceutical agent 114. Theexternal energy unit 10 may be used to apply energy to selectivelyrelease a layer of the biodegradable coating 120, releasing thecorresponding pharmaceutical agent 114. Each of the layers or sectionsof the biodegradable coating 120 may be released as needed or at settime intervals.

Non-limiting examples of the biodegradable coating 120 include polyacticacid (“PLA”), polyglycolic acid (“PGA”), and copolymers thereof. Thedegradation rate of the biodegradable coating can be controlled by theratio of PLA to PGA, or by the thickness or density of the coating.Additionally, the biodegradable coating 120 may also include collagen,cellulose, fibrin, or other cellular based compounds.

In an alternate embodiment, the polymer coating includes micro capsules,spheres, or crystals affixed to and around the stent 112. Thepharmaceutical agent 114 is contained within the micro capsule, spheres,or crystals. In operation, the external energy unit 10 may be positionedover the stent 112, providing energy at a frequency to heat the stent112 and polymer coating 116, breaking off a number of the micro capsulesfrom the stent 112. The applied energy increases the degradation,fragmentation, or dissolution rate of the micro capsules to acceleratethe release of the pharmaceutical agent 114. After a therapeutic amountof the pharmaceutical agent 114 has been released, the energy may bediscontinued.

While the foregoing exemplary embodiment was depicted specifically witha stent 112, in alternate embodiments, similar techniques may be used tocoat other types of implantable medical devices, such as hip and kneereplacement (total and partial), spinal implants, scaffold, biologicalimplants or grafts, tissue grafts, screws, plates, rods, prostheticdevices, etc. A wide array of types of drugs may be delivered in asimilar fashion as described above. For example, steroidal,nonsteroidals, pain relieving drugs, hormones, cells, stem cells, bonemorphogenic proteins (BMPs), enzymes, proteins, RNA, and other agentsmay be delivered intraoperatively or postoperatively. In this regard,the coated implant may advantageously be used as a multimodal treatmentregimen with postoperative analgesic pain relief and accelerate tissuehealing. This may be particularly advantageous for cementlessimplantation, disc replacement, tissue grafts, cellular therapy, genetherapy, implanted organs such as kidney transplants or partialimplants, among other applications.

In an embodiment, the implantable medical device 12 may be at leastpartial made of a biodegradable material. Non-limiting examples of thebiodegradable materials include polyactic acid (“PLA”), polyglycolicacid (“PGA”), and copolymers thereof. The degradation rate of thebiodegradable materials can be controlled by the ratio of PLA to PGA.Additionally, the biodegradable material may also include collagen,cellulose, fibrin, or other cellular based compounds.

As described above, a pharmaceutical agent 114 may be affixed to thebiodegradable implant by coating, mixing, or bonding the pharmaceuticalagent 114 to a polymer coating 116 applied to the biodegradable implant.In this regard, the polymer coating 116 may be configured to be areactive coating, reacting to energy provided by an external energy unit10.

In another alternate embodiment, the biodegradable implant may beimpregnated with the pharmaceutical agent 114. In operation, theexternal energy unit 10 may be positioned over the biodegradableimplant, providing energy at a frequency to heat the biodegradableimplant, partially breaking-up or fragmenting a portion of thebiodegradable implant. The applied energy increases the degradation,fragmentation, or dissolution rate of the biodegradable implant, toaccelerate the release of the pharmaceutical agent 114. After atherapeutic amount of the pharmaceutical agent 114 has been released,the energy may be discontinued. The biodegradable implant may be attunedfor activation at substantially the same frequency as the energyfocusing device 28. Alternatively, biodegradable implant may be attunedto be activated at different frequency from that of the energy focusingdevice 28.

In an alternate embodiment, biodegradable implant may include aplurality of layers or sections, each including a different therapeuticamount of a pharmaceutical agent 114. The external energy unit 10 may beused to apply energy to selectively release a layer of the biodegradableimplant, releasing the corresponding therapeutic amount of apharmaceutical agent 114. Each of the layers or sections of thebiodegradable implant may be released as needed or at a set timeintervals.

In an alternate embodiment, the biodegradable implant is made up ofmicro capsules, spheres, or crystals. The pharmaceutical agent 114 iscontained within the micro capsule, spheres, or crystals. In operation,the external energy unit 10 may be positioned over the biodegradableimplant, providing energy at a frequency to heat the biodegradableimplant, breaking off a number of the micro capsules. The applied energyincreases the degradation, fragmentation, or dissolution rate of themicro capsules to accelerate the release of the pharmaceutical agent114. After a therapeutic amount of the pharmaceutical agent 114 has beenreleased, the energy may be discontinued.

Referring to FIG. 17, in another embodiment, the implanted medicaldevice 12 may include a heat sink 130, wherein the heat sink 130 may beincorporated into the medical device 12 or be positioned separate fromthe medical implant 12. The heat sink 130 is configured to absorb energyfrom the external energy unit 10, converting the energy into heatenergy. The heat sink 130 stores and releases the heat energy to thetreatment site over time, creating a localized increase in temperature.In one embodiment, the heat is stored in the heat sink 130 until thetemperature in the surrounding tissue decreases to a thresholdtemperature. At this point, heat is released from the heat sink 130.

The beneficial effects of the localized increase in temperature include(but are not limited to): aiding in the alleviation of localized pain,fighting of local infections, and increasing vascular flow andpermeability of vessels at the treatment site. For example, the heatsink 130 may be positioned during a surgical procedure to aid in thehealing of the surgical site. The heat sink may provide a local increasein temperature at the surgical site, aiding the healing and increasingthe vascularity at the surgical site to control delivery of medicamentsto the surgical site.

When used in conjunction with the energy focusing device 28, theprolonged heat energy released by the heat sink 130 can soften up plaqueor particulate material at the treatment site. This can assist in thefragmentation of particulate material or aid in the breaking-up of theplaque. Additionally, the heat sink 130 can be used for concentrating apharmaceutical or therapeutic agent delivery in a localized area.

In another embodiment, the implanted medical device 12 may include a pHsink, wherein the pH sink may be incorporated into the medical device 12or be positioned separate from the medical implant 12. The pH sink 130is configured to absorb energy from the external energy unit 10,releasing a chemical to either increase or decreasing the local pH. Forexample, the pH sink includes a basic material which is released uponthe application of the energy.

One potential use of this embodiment is the prevention and treatment ofosteoporosis. Calcium from bones is used to counteract acidicconditions, leading to bone stock with decreased mineral content. Thisuptake of calcium can be reduced with a pH sink that releases a basicsubstance in the presence of an acidic environment.

Referring to FIG. 18, one embodiment of the present disclosure mayfurther include a partially coated wire 132, for insertion into a vein,artery, or other vessel. The partially coated wire 132 includes aninsulated coating 134, having an exposed portion 136 at its distal end.In operation, the exposed portion 136 may be positioned in the treatmentsite, adjacent to the plaque or particulate material to be fragmented.The partially coated wire 132 can be percutaneously or transcutaneouslyinserted into the vessel, wherein the partially coated wire 132 is movedthrough body of the patient to the treatment site. An external powersource 138 is connected to the wire, such that energy may be provided tothe treatment site from the exposed portion 136. The insulted coating134 prevents the release the energy along the length of the coated wire,protecting the adjacent tissue. The released energy can take the form ofacoustic or heat energy, aiding in the fragmentation of particulatematerial or removal of plaque.

Rather then being a wire with a solid core, a catheter 132, having alumen, can be used for insertion into a vessel. The catheter includes aninsulated coating 134, having an exposed portion on the distal end. Inoperation, the exposed distal end may be positioned in the treatmentsite, adjacent to the plaque or particulate material to be fragmented.The catheter can be percutaneously or transcutaneously inserted into thevessel, wherein the distal end of the catheter is moved through the bodyof the patient to the treatment site. An external or partially implantedpower source 138 is connected to the catheter, such that energy may beprovided to the implantable medical device 12 from the distal end of thecatheter. The released energy can take the form of radio frequency (RF),magnetic, electro magnetic (EM), acoustic, microwave, thermal,vibratory, optical laser, or heat energy, aiding in the fragmentation ofparticulate material or removal of plaque.

Referring to FIG. 19, in another embodiment an expandable cannula 140may be used to position an energy transmission unit 142 in proximity tothe medical device 12 of the present disclosure. Exemplary expandablecannulas are disclosed in U.S. Pat. No. 5,961,499, to Bonutti, and U.S.Pat. No. 5,431,676, to Dubrul et al., the contents of which areincorporated by reference. In one exemplary practical application ofthis embodiment, the implanted medical device 12 may be surgicallypositioned on or proximal to an outer surface of the aorta 74 of theheart 76. The implanted medical device 12 is positioned adjacent to atreatment site 78, an area of recurring clotting or stenotic area. Theexpandable cannula 140 is inserted through the skin 144 of the patient,until a tip portion is proximal to the implanted medical device 12. Theexpandable cannula 140 is expanded, increasing the diameter of theexpandable cannula 140. The energy transmission unit 142 is positionedthrough the expandable cannula 140, in proximity to the implantedmedical device 12. A power source (“PS”) 146 provides energy to theenergy transmission unit 142, activating the energy focusing device 28of the implanted medical device 12. The energy focusing device 28creates a convergent point shockwave focused from the implanted medicaldevice 12, into the clot or stenotic area, breaking-up or fragmentingthe clot or stenotic area.

In the above embodiments, the present disclosure utilizes an externalenergy unit 10 or external power source 138 to provide energy to theimplanted medical device 12. In an alternative embodiment shown in FIG.20, an internal energy unit 148 unit may be surgical or percutaneouslypositioned proximal to the implanted medical device 12. Imagingtechniques, such as MRI, CT scan, ultrasound, x-ray, fluoroscope, etc.,may be used in the implantation of the internal energy unit 148 andmedical device 12. An expandable cannula 140 may be used to position aninternal energy unit 148 in proximity to the implantable medical device12. The expandable cannula 140 is inserted through the skin 144 of thepatient, until a tip portion is proximal to the implanted medical device12. The expandable cannula 140 is expanded, increasing the diameter ofthe expandable cannula 140. The internal energy unit 148 is positionedthrough the expandable cannula 140, in proximity to the implantedmedical device 12. The expandable cannula 140 is removed, and theinsertion site sealed. The internal energy unit 148 is positioned toprovide energy to the implanted medical device 12 to activate the energyfocusing device 28.

The internal energy unit 148 includes a battery for providing power. Ifthe battery has a limited life span, the internal energy unit 148 may besurgically or percutaneously removed and/or replaced. As describedabove, an expandable cannula 140 may be used to remove the internalenergy unit 148. The expandable cannula 140 is inserted through the skin144 of the patient, until a tip portion is proximal to the implantedmedical device 12. The expandable cannula 140 is expanded, increasingthe diameter of the expandable cannula 140. The internal energy unit 148is removed through the expandable cannula 140. A replacement internalenergy unit 148 may then be positioned through the expandable cannula140, in proximity to the implanted medical device 12. The expandablecannula 140 is removed, and the insertion site sealed.

Alternatively, the internal energy unit 148 may include a rechargeablebattery. As described above and in FIG. 12, the rechargeable battery 110may be recharged by positioning an external energy unit 10 on the skinof the patient's body, aligned with the rechargeable battery 110. Energyis transmitted through the body of the patient to the rechargeablebattery 110.

In the above embodiment, the rechargeable battery 110 is described asrequiring an external energy unit 10 to be recharged. However it iscontemplated, that the rechargeable battery 110 can include aself-recharging mechanism. The self-recharging mechanism utilizes themovement of the patient to generate power to recharge the rechargeablebattery.

As described in FIG. 11, the internal energy unit 148 may include acontrol unit 100. In operation, the control unit 100 is configured toselectively activate the energy focusing device 28 at pre-programmed settime intervals. Alternatively, the implantable medical device 12includes sensor assemblies 80. As set time intervals, the control unit100 activates the sensor assemblies 80 to take data readings of thetreatment site. In response to these measurements, if required, thecontrol unit 100 may also selectively activate one or more energyfocusing device(s) 28 to break-up or fragment particulate material.After an initial treatment with the energy focusing device(s) 28, thetreatment site may be re-assessed to determine if further treatment isrequired. This process may be repeated until the treatment site issubstantially free of particulate material, as may be determined bypre-set parameters programmed into control unit 100.

In the above examples, the present disclosure has been described astreating clotting and stenotic areas in the heart. However, it iscontemplated that the present disclosure can be used on any organ,joint, or portion of the body requiring breaking or fragmenting ofparticulate material either alone, or in combination with drug delivery,tissue graft, or cell therapy. Additionally, the present disclosure canbe used in conjunction with pharmaceutical treatment, which can resultin a decrease in the dosage of the pharmaceutical or a decrease in thetreatment period.

In an another exemplary practical application of an embodiment accordingto the present disclosure, the external energy units 10 may be used toprevent or treat the formation of deep vein thrombosis (“DVT”). Thetreatment may be done on a daily basis or an occasional basis, duringsurgery, during long period of inactivity, or as part of apost-operative treatment. For example, on long airplane flights, such astransatlantic or transpacific flights, passengers typically remain in acramped seated position for extended periods of time, which can resultin the formation of DVT. In this situation, the external energy units 10may be positioned on a passenger, and used to prevent and/or treat DVT.

The treatment of DVT (particularly as part of a post-operative therapy)traditionally includes the application of pharmaceutical agents, such asanti-coagulants or blood thinners to prevent the formation and break-upclotting or plaque formations. For example, a treatment of 2-10 mg ofwarfain sodium, COUMADIN, may be required for 3-6 month. However, theuse of such pharmaceutical agents have adverse side effects, includingbleeding, infection, hemarthrosis, pain, and in extreme cases death.

The external energy units 10 of the present disclosure may be used inthe prevention or treatment of DVT (either as an alternative or as anadjunct to drug treatment), having the additional beneficial effect ofdecreasing the use, the dosage and/or duration of the pharmaceuticalagents. Referring to FIGS. 21 and 22, a plurality of external energyunits 10 may be positioned about a patient, for example, a leg 150 of apatient. The external energy units 10 may be positioned on the skin ofthe leg 150 of the patient. Each of the external energy units 10 isoperably connected to a power supply 154, including a controller unit156 for selectively activating the individual external energy units 10.The external energy units 10 are configured to direct energy 158 intothe leg 150 of the patient to breakup any type of thrombin or clotformation 160. When used in conjunction with the pharmaceutical agents,the external energy unit 10 may allow for a decrease in the dosage orduration of use of the pharmaceutical agents. This may result in adecrease in the occurrence and severity of the unwanted side effect ofthe pharmaceutical agents. In some instance, the external energy unit 10may be used in lieu of the pharmaceutical agent, removing the occurrenceof the unwanted side effects.

The controller unit 156 may selectively activate the external energyunits 10 in a continuous sequence or in a pulsating sequence. Apulsating sequence produces a pulsed energy 158 directed into the leg150 of the patient. The directed energy 158 can include, but not belimited to, ultrasonic, vibratory, microwave, RF, EM, ESW, or othertypes of energy, in a pulsed monomodal, and/or multimodal form.

The external energy units 10 may be removable attached to the leg 150 ofthe patient using an adhesive material. For example, each of the energyunits 10 may include an adhesive backing for affixation to the leg 150of the patient. The adhesive backing allows the energy units 10 to beeach attached to and removed from the leg 150 of the patient.

Alternatively, the external energy units 10 may be integrated into anappliance 152 fitted about the leg 150 of the patient, positioning theexternal energy units 10. The appliance 152 may take the form of anelastic sleeve, wherein the elastic sleeve provides a continual pressureabout the leg 150 of the patent. Alternatively, the appliance 152 may bea compressive stocking, TED hose, tourniquet, pulsatile stocking, orother graduated compressive device.

In an embodiment, the appliance 152 may be a pulsatile stocking Apulsatile stocking is used to applying compressive pressure to the leg150 of the patient. The pulsatile stocking provides intermittent pulsesof compressed air which sequentially inflate multiple chambers in thestocking, resulting in a wave-like milking action which forcibly assistsblood flow through the veins and results in greatly increased peak bloodflow velocity. The pulsatile stocking is configured to be slidablypositionable about the leg 150 of the patient, allowing for optimalpositioning of the external energy units 10 for treatment.

The external energy units 10 are integrated to the pulsatile stockingand may be used in conjunction with the wave-like milking action ofpulsatile stocking to breakup or prevent any type of thrombin or clotformation 160. As the intermittent pulses of compressed air sequentiallyinflate multiple chambers in the pulsatile stocking, the controller unit156 activates the energy units 10, directing energy 158 into the leg150. The controller unit 156 may selectively activate the externalenergy units 10 in a continuous sequence or in a pulsating sequenceproducing a pulsed energy 158. The combination of the wave-like milkingaction of the pulsatile stocking and directed energy 158 from theexternal energy units 10 work in unison to prevent the formation of andbreak-up clotting or plaque formations 160.

Referring to FIGS. 21 and 23, implanted medical devices 12 of thepresent disclosure can be surgically positioned on and about a vessel162, for example in the leg 150, at locations of reoccurring clotting160. As discussed above, implantable medical device 12 may includeenergy focusing device(s) 28 which may be activated by the externalenergy units 10. The plurality of external energy units 10 arepositioned on the leg 150 of the patient and at least some of theexternal energy units 10 are aligned with implanted medical devices 12.At set time intervals, external energy units 10 may be selectivelyactivated, activating the correspondingly aligned energy focusingdevices 28. The external energy units 10 and energy focusing devices 28are positioned such that pulsed energy may be selectively directed intothe leg of the patient to fragment/prevent clotting or plaqueformations.

As noted above, the external energy units 10 may be integrated into anappliance 152 which is fitted about the leg 150 of the patient. Theappliance 152 may be a compressive stocking, TED hose, tourniquet,pulsatile stocking, or other graduated compressive device. For example,when the appliance 152 is a pulsatile stocking, the external energyunits 10 may selectively activate correspondingly aligned energyfocusing devices 28 which work in conjunction with the wave action ofthe pulsatile stocking.

Referring to FIG. 24, in another embodiment a pulsatile stocking 170 canbe used in conjunction with the appliance 152 of FIG. 19. The pulsatilestocking 170 is used to applying compressive pressure to a lower portionof the leg 150 of the patient. The pulsatile stocking 170 providesintermittent pulses of compressed air which sequentially inflatemultiple chambers in the sleeve 170, resulting in a wave-like milkingaction which forcibly assists blood flow through the veins and resultsin greatly increased peak blood flow velocity. The pulsatile stocking170 is configured to be slidably positionable on the lower portion ofthe leg 150 of the patient, allowing for optimal positioning fortreatment. Alternatively, a compressive stocking, TED hose, tourniquet,or other graduated compressive device fitted about the leg 150 of thepatient can be used.

In the above examples, the appliance 152 or pulsatile stock 170 isdescribed as fitting over the leg portion of the patient. However, it iscontemplated that the appliance 170 or pulsatile stocking 152 can befitted over any portion of the body of the patent. It is alsocontemplated that an appliance and pulsatile device can be fitted overthe trunk or pelvic portion of the body of the patient. For example, theappliance can take the form of a mast compression stocking, which can befitted about the trunk, thigh, and limbs of the patient. Similarly, theappliance or pulsatile device can be fitted about the trunk of thepatient, for use after spinal or pelvic surgery.

Referring to FIG. 25, in an embodiment the implanted medical devices 12of the present disclosure are surgically positioned along and about avein, artery, or other vessel 172. As discussed above, implantablemedical device 12 may include energy focusing device(s) 28 which may beactivated by the external energy units 10. A first energy focusingdevice 174 is positioned proximal to a treatment site 176. The firstenergy focusing device 174 may selectively direct a convergent shockwaveinto the treatment site 176 to break-up or fragment the particulatematerial 178. Additional energy focusing devices 180 and 182 arepositioned downstream of the treatment site, directing convergentshockwaves into the vessel 172.

As the broken-up or fragmented particulate material 178 travels from thetreatment site 176 downstream, through the vessel 172, it will passthrough the convergent shockwaves. The convergent shockwaves, furtherbreak-up or fragment the particulate material 178. The broken-up orfragmented particulate material 178 is decreased in size, such that theparticulate material can be safely passed through the body, eliminatingthe need for the use of a filtering device, such as GREENFIELD filter.

A sensor assembly 183 can be further included. The sensor assembly 183may be used to detect the fragmented particulate material 178 travelingthrough the vessel 172 and activate the down stream energy focusingdevices 180 and 182 to further break-up fragmented particulate material178.

Referring to FIG. 26, the energy focusing device(s) 28 of the presentdisclosure may be positioned in the body of the patient a distance F1from the treatment site 184. The distance F1 is selected such that theconvergent shockwave 186 is focused into the treatment site 184. Whenused to break-up or fragment particulate material in a small vessel, thediameter and surface area of the vessel may be insufficient toaccommodate the energy focusing device(s) 28 or permit the convergentshockwave 186 to be located at the treatment site 184 (e.g. with thelumen of the vessel). The energy focusing device(s) 28 may be positionedproximal to the vein at a distance F1 from the treatment site 184,allowing the convergent shockwave 186 to be directed into the treatmentsite 184.

All references cited herein are expressly incorporated by reference intheir entirety. In addition, unless mention was made above to thecontrary, it should be noted that all of the accompanying drawings arenot to scale. There are many different features to the presentdisclosure and it is contemplated that these features may be usedtogether or separately. Thus, the disclosure should not be limited toany particular combination of features or to a particular application ofthe disclosure. Further, it should be understood that variations andmodifications within the spirit and scope of the disclosure might occurto those skilled in the art to which the disclosure pertains.Accordingly, all expedient modifications readily attainable by oneversed in the art from the disclosure set forth herein that are withinscope and spirit of the present disclosure are to be included as furtherembodiments of the present disclosure. The scope of the presentdisclosure is accordingly defined as set forth in the appended claims.

1-43. (canceled)
 44. A device for transmitting focused acoustic energyfrom a tissue surface of a face of a user to at least one sinus, thedevice comprising: a power supply; a signal source configured to providea waveform of at least 20 kHz that is configured to increase a flow offluid from the at least one sinus; and a transducer connected to thepower supply and the signal source, the transducer configured to contacta medium applied to the tissue surface of the face and transmit thewaveform through the medium and the tissue surface of the face to the atleast one sinus.
 45. The device of claim 44, wherein the power supplyincludes a battery.
 46. The device of claim 44, wherein the power supplyincludes a converter configured to convert AC power to DC power.
 47. Thedevice of claim 44, wherein the transducer is a patch attached to thepower supply with a flexible member.
 48. The device of claim 44, whereinthe signal source is configured to modulate between waveforms ofdifferent frequencies.
 49. A device for transmitting focused acousticenergy from a tissue surface of a face of a user to at least one sinus,the device comprising: a power supply; a signal source configured toprovide a waveform of at least 20 kHz that is configured to reduce localinfections within the at least one sinus; and a transducer connected tothe power supply and the signal source, the transducer configured tocontact a medium applied to the tissue surface of the face and transmitthe waveform through the medium and the tissue surface of the face tothe at least one sinus.
 50. The device of claim 49, wherein the powersupply includes a battery.
 51. The device of claim 49, wherein the powersupply includes a converter configured to convert AC power to DC power.52. The device of claim 49, wherein the transducer is a patch attachedto the power supply with a flexible member.
 53. The device of claim 49,wherein the signal source is configured to modulate between waveforms ofdifferent frequencies.
 54. The device of claim 49, wherein the waveformis further configured to alleviate localized pain within the face. 55.The device of claim 49, wherein the waveform is configured to increase aflow of fluid from the at least one sinus.
 56. The device of claim 49,wherein the waveform is configured to change a pH in the at least onesinus.
 57. A device for transmitting focused acoustic energy from atissue surface of a face of a user to at least one sinus, the devicecomprising: a power supply; a signal source configured to provide awaveform of at least 20 kHz configured to alleviate localized painwithin the face; and a transducer connected to the power supply and thesignal source, the transducer configured to contact a medium applied tothe tissue surface of the face and transmit the waveform through themedium and the tissue surface of the face to the at least one sinus. 58.The device of claim 57, wherein the power supply includes a battery. 59.The device of claim 57, wherein the power supply includes a converterconfigured to convert AC power to DC power.
 60. The device of claim 57,wherein the transducer is a patch attached to the power supply with aflexible member.
 61. The device of claim 57, where in the signal sourceis configured to modulate between waveforms of different frequencies.62. The device of claim 57, wherein the waveform is configured toincrease a flow of fluid from the at least one sinus.
 63. The device ofclaim 57, wherein the waveform is configured to change a pH in the atleast one sinus.